The following data is part of a premarket notification filed by Voss Medical Products with the FDA for Prone Positioner.
| Device ID | K932187 |
| 510k Number | K932187 |
| Device Name: | PRONE POSITIONER |
| Classification | Positioner, Socket |
| Applicant | VOSS MEDICAL PRODUCTS 1920 N STREET,N.W. SUITE 650 Washington, DC 20036 |
| Contact | Bruce Mackler |
| Correspondent | Bruce Mackler VOSS MEDICAL PRODUCTS 1920 N STREET,N.W. SUITE 650 Washington, DC 20036 |
| Product Code | KIL |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-05 |
| Decision Date | 1993-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811304020102 | K932187 | 000 |